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  • MFDS reveals detailed clinical trial inspection plan
  • by Lee, Tak-Sun | translator Byun Kyung A | Feb 20, 2020 06:35am
MFDS says bioequivalence test would be dealt by Drug Equivalence Division and Regional Offices
Sponsors, CRO, institutes should enhance inspection capacity
Clinical Trial Management Division unveils 2020 Master Plan
Korea¡¯s Ministry of Food and Drug Safety (MFDS) plans to conduct extensive inspection on clinical trial regarding pharmaceutical approval. The subjects are new drugs and drugs required to submit evidential data. Accordingly, pharmaceutical companies, CRO, and healthcare institutes would be investigated by Clinical Trial Management Division of MFDS. But, bioequivalence test covered under Good Clinical Practice (GCP) would be investigated by Pharmaceutical Equivalence Division and MFDS Regional Office as usual.

As of Feb. 11, MFDS disclosed ¡®Master Plan 2020 for Pharmaceutical Clinical Trial Audit and Inspection¡¯ on its website.

The plan specified ¡®the authority would inspect clinical trial institute and sp
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